Clinical trials: Performance, Detection
Bloodstream Infection, Sepsis
Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care…
- Conditions
- Bloodstream Infection, Sepsis, Septic Shock
- Trial name
- IID-BSIqPCR (NCT06531031)
- Testing
- InfectID-BSI (Bloodstream Infection) qPCR Assay
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 1,500 people
- Sponsor
- Microbio Co Ltd
Chronic Chagas
Prospective Evaluation of Rapid Diagnostic Tests for Trypanosoma Cruzi Infection
Chagas disease (CD) is the most significant endemic zoonosis in Argentina. Two-thirds of affected individuals live in urban areas but only 10% globally are aware of their infection.
- Trial name
- NCT07304349
- Where
- 4 sites in Argentina
- Volunteers
- 3,234 people, healthy volunteers welcome
- Sponsor
- Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben
Influenza A, Influenza B
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase…
- Trial name
- NCT02487173
- Testing
- Respirio Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Sofia® Influenza A+B Fluorescent Immunoassay (FIA)
- Where
- 4 sites in Australia
- Volunteers
- 83 people
- Sponsor
- Ellume Pty Ltd
UGI Bleed
A Prospective Pilot Study to Evaluate the Diagnostic Performance of a Wireless Sensor Capsule in Detection of UGIB
It is a single-center, prospective study, which will be conducted in a tertiary academic hospital (Prince of Wales Hospital). All subjects will undergo a paired examination of HemoPill® acute capsule and…
- Trial name
- HemoPill (NCT06409182)
- Testing
- Hemopill
- Where
- Hong Kong
- Volunteers
- 30 people
- Sponsor
- Chinese University of Hong Kong
Celiac Disease in Children
Anti-Tissue Transglutaminase IgA Antibodies
Celiac disease is the most common genetically related food intolerance, worldwide. It is an immune mediated intolerance to gluten (from wheat, barley, or rye) in genetically susceptible individuals .The disease primarily affects…
- Trial name
- NCT04019223
- Testing
- anti-tissue transglutaminase group, biopsy group
- Volunteers
- 22 people
- Sponsor
- Assiut University
Cerebral Malaria, Malarial Retinopathy
Automated Detection of Malarial Retinopathy in Patients Diagnosed With Cerebral Malaria
The focus of the study is performance validation of ASPIRE software device in processing mydriatic retinal images of a patient with clinically diagnosed Cerebral Malaria (CM), to detect malarial retinopathy (MR).
- Trial name
- ASPIRE (NCT06915285)
- Testing
- Automated software for malarial retinopathy detection
- Where
- Malawi
- Volunteers
- 834 people
- Sponsor
- VisionQuest Biomedical LLC
HIV Infections
Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test
To determine the efficacy of an improved rapid diagnostic test using venous whole blood and fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will be determined by comparing the results with…
- Trial name
- NCT02190578
- Testing
- Reveal G4
- Where
- 4 sites in United States
- Volunteers
- 1,649 people, healthy volunteers welcome
- Sponsor
- MedMira Laboratories Inc.
Malaria, RDT
Abbott NxTekTM Malaria RDT WHO Prequalification Study
Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have dramatically improved our ability to control malaria but proved insufficient to support elimination efforts because of their limited sensitivity…
- Conditions
- Malaria, RDT, Diagnoses Disease
- Trial name
- NCT05444790
- Testing
- Rapid Diagnostic Test
- Where
- 3 sites in Indonesia, Peru and 1 more
- Volunteers
- 4,563 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Malaria
Performance Evaluation of Malaria Plus RDTs
Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have dramatically improved our ability to control malaria, but proved insufficient to support elimination efforts because of their limited sensitivity…
- Trial name
- NCT03960632
- Testing
- Abbott SD Bioline Malaria Pf Plus (05FK150) and Abbott SD Bioline Malaria Pf/Pv Plus (05FK160))
- Volunteers
- 6,546 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Immunodeficiency and Suspected Infection
Evaluation of High Throughput Sequencing for Screening of Pathogens in Immunocompromised Patients With Suspected Infectious Disease.
The study patients are patients suffering from primary or secondary immunodeficiencies investigated in the Hospital Necker for a suspected infectious disease.
- Trial name
- PATHOQUEST1 (NCT02007642)
- Testing
- Blood sampling / Body fluid sampling
- Where
- 2 sites in France
- Volunteers
- 250 people
- Sponsor
- Pathoquest
Fracture
AI Performance for the Detection of Bone Fractures in Children
The artificial intelligence (AI) software BoneView (GLEAMER Company, Paris, France) has been designed, tested and validated to detect and locate recent or semi-recent fractures on standard radiographs.
- Trial name
- NCT05538403
- Where
- France
- Volunteers
- 210 people
- Sponsor
- University Hospital, Montpellier
Respiratory Tract Infection Viral
Comparison Between Different Sampling Sites for Detection of Respiratory Viruses
The goal of this observational study is to validate the use of less invasive samples (saliva, orobuccal or nasal swabs) than nasopharyngeal swab for testing common and clinically relevant respiratory viruses in children and…
- Trial name
- ORASAMP (NCT06743750)
- Testing
- RT-PCR in different respiratory tract samples
- Where
- Switzerland
- Volunteers
- 501 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Diabetic Autonomic Neuropathy, Diabetic Neuropathy
High Diagnostic Performance of the Indicator Plaster Neuropad for the Detection of Diabetic Autonomic Neuropathy
Diabetic autonomic neuropathy (DAN) is a prevalent and severe complication of Diabetes Mellitus (DM). When the autonomic regulation of the cardiovascular system is affected, it is referred to as cardiovascular autonomic…
- Trial name
- NCT06734143
- Testing
- Neuropad
- Where
- Greece
- Volunteers
- 174 people
- Sponsor
- Aristotle University Of Thessaloniki
Pulmonary Infection
mNGS for Detection of Pathogens for Pulmonary Infection
Pulmonary infections remain the leading causes of morbidity and mortality among patients worldwide. Pathogen identification is crucial yet difficult for the majority of the cases.
- Trial name
- NCT03798925
- Testing
- None Intervention
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Sir Run Run Shaw Hospital
COVID-19, Coronavirus Disease 2019
SARS-CoV-2 Nucleic Acid Detection Kit Clinical Performance Study
SARS-CoV-2 Nucleic Acid Detection Kit is an In Vitro Diagnostic (IVD) medical device intended for RNA detection of SARS-CoV-2 in human specimens using multiplex real-time polymerase chain reaction (RT-PCR) technology.
- Conditions
- COVID-19, Coronavirus Disease 2019, COVID-19 Pandemic, Diagnoses Disease
- Trial name
- CPS CW008 (NCT05492227)
- Testing
- Left-overs
- Where
- Spain
- Volunteers
- 607 people, healthy volunteers welcome
- Sponsor
- TransGen Biotech Co., LTD
SARS-CoV-2 Infection
EuGeni Rapid Antigen Test for the Qualitative Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Causing COVID19 Disease in Compliance With the World Health Organization (WHO)
Rapid antigen detection (RAD) tests are used to perform rapid diagnosis of SARS-CoV-2 infection based on a qualitative approach.
- Trial name
- WHO (NCT05618561)
- Testing
- EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test
- Where
- 5 sites in Croatia, Greece and 1 more
- Volunteers
- 599 people, healthy volunteers welcome
- Sponsor
- AnteoTech Ltd
Malaria
Evaluating the Clinical Performance and Usability of Novel Malaria RDTs in Brazil
Prospective cross-sectional diagnostic accuracy study with 1,000 patient participants and 30 lay provider/health care worker participants. The patient participant population will be recruited at clinics.
- Trial name
- NCT05317117
- Testing
- NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDT
- Where
- Brazil
- Volunteers
- 1,030 people, healthy volunteers welcome
- Sponsor
- PATH
Hereditary Cancer Syndrome
CfDNA in Hereditary And High-risk Malignancies 2
The goal of this study is to understand the performance of an experimental blood test that aims to detect early tumors in patients with hereditary cancer syndromes.
- Trial name
- CHARM2 (NCT06726642)
- Testing
- Cell-free DNA analysis
- Where
- 8 sites in Canada
- Volunteers
- 1,000 people
- Sponsor
- University Health Network, Toronto
Uterine Neoplasms, Cervical Cancer
Prospective Cohort Study of Minimal Residual Disease(MRD) Testing for Early Recurrence Detection in Endometrial and Cervical Cancer
This study aims to evaluate the clinical performance of blood-based Minimal Residual Disease (MRD) testing using circulating tumor DNA (ctDNA) in patients with endometrial and cervical cancer.
- Trial name
- NCT07382505
- Testing
- Serial blood collection for MRD testing
- Where
- South Korea
- Volunteers
- 600 people
- Sponsor
- Asan Medical Center
Healthy Volunteer
Diagnostic Performance of Gastric Ultrasound in Children
Pulmonary aspiration of gastric contents is a complication responsible for the third highest cause of anaesthesia-related mortality in France, and for 50% of airway management-related mortality in the UK.
- Trial name
- QUALIGASTR (NCT06079268)
- Testing
- the initial gastric ultrasound, the gastric ultrasound last 3 minutes
- Where
- France
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon